Berberis Vulgaris Consumption and Blood Pressure

Overview

The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ < 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.

Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.

Full Title of Study: “Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: February 22, 2020

Interventions

  • Dietary Supplement: berberis vulgaris=barberry
    • 10 grams of barberry powder will be consumed daily for 8 weeks.
  • Dietary Supplement: Placebo
    • Placebo powder

Arms, Groups and Cohorts

  • Active Comparator: Barberry
    • Daily consumption of barberry in powder form.
  • Placebo Comparator: placebo
    • Daily consumption of placebo powder.

Clinical Trial Outcome Measures

Primary Measures

  • ABPM
    • Time Frame: After 8 weeks
    • Ambulatory 24 h blood pressure monitoring

Secondary Measures

  • lipid profile
    • Time Frame: After 8 weeks
    • TC, LDL-C, HDL-C, TG
  • plasma NOx
    • Time Frame: After 8 weeks
    • concentration of nitrite and nitrate in plasma
  • Inflammatory cytokine
    • Time Frame: After 8 weeks
    • Plasma Interleukin-6

Participating in This Clinical Trial

Inclusion Criteria

  • willingness to participate in the study
  • age between 20-65 years
  • having elevated BP (129/ < 85) and known hypertensive patients on medical treatment
  • at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus

Exclusion Criteria

  • Unwillingness to continue participation
  • BMI> 30
  • patients on nitrates
  • high doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day)
  • consumption of vitamins or minerals supplements during past month
  • Chronic kidney disease stage 4 or 5

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shahid Beheshti University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Javad Nasrollahzadeh, Academic Member – Shahid Beheshti University of Medical Sciences

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